Safety and Efficacy Evaluation of Topically Applied AN2690 Solutions for Subjects With Onychomycosis

This study has been completed.
Sponsor:
Information provided by:
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00680134
First received: May 15, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

The purpose of the study is to determine the safety and efficacy of 1% and 5% AN2690 solutions in the treatment of distal, subungual onychomycosis of the great toenail.


Condition Intervention Phase
Onychomycosis
Drug: AN2690
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Multi-Center Study to Evaluate the Safety and Efficacy of Topically Applied AN2690 1% and 5% Solutions for the Treatment of Adult Subjects With Onychomycosis of the Great Toenail

Resource links provided by NLM:


Further study details as provided by Anacor Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Complete or partial clinical evidence of great toenail clearance or at least 2 mm of fungal clear linear great toenail growth plus a negative fungal culture from the treatment targeted toenail at the End-of-treatment (Day 180) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluations of mycological response, changes from baseline linear toenail growth, proportion of subjects who are successful "Complete Responders" [ Time Frame: Day 180 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group/Cohort 1
AN2690 1% Solution (30 subjects)
Drug: AN2690
AN2690 1% Solution, once daily for 180 days
Experimental: Group/Cohort 2
AN2690 5% Solution (30 subjects)
Drug: AN2690
AN2690 5% Solution, once daily for 30 days; 3x weekly for 150 days

Detailed Description:

The first group of 30 protocol-qualified subjects will be assigned to Treatment Group 1 and given 1% AN2690 Solution. The second group of 30 protocol-qualified subjects will be assigned to Treatment Group 2 and given 5% AN2690 Solution.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Witnessed, signed informed consent approved by Institutional Review Board/Ethics Committee
  • A signed Health Insurance Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of subject's individually identifiable health information for those enrolled in the United States of America
  • Male or female subjects of any race 18 -65 years of age
  • Subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount and a positive fungal culture for dermatophyte species
  • Onychomycosis involving 20-60% of the affected great toenail as determined at baseline (Day1) by visual inspection after the nail has been trimmed
  • The combined thickness of the distal nail plate and the associated hyperkeratotic nail bed <3 mm
  • Affected great toenail to be treated is capable of re-growth as documented by history or recent observation of at least 2 mm of growth

Exclusion Criteria:

  • Females of childbearing potential not using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices) during the study
  • Subjects unwilling to refrain from the use of nail cosmetics such as clear and or colored nail lacquers from the screening visit until the end of the study
  • Subjects with chronic moccasin type of T. pedis
  • Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis
  • Diabetes mellitus requiring treatment other than diet and exercise
  • Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications:

    1. Topical antifungal applied to toenails (does not include antifungals for treatment of T. pedis): 12 weeks
    2. Anti-inflammatories, corticosteroids, topical immunomodulators (in the treatment area): 2 weeks
  • Subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications:

    1. Corticosteroids (including intramuscular injections): 2 weeks
    2. Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophyte species: 24 weeks
    3. Systemic immunomodulators: 4 weeks
  • Treatment of any type for cancer within the last 6 months
  • History of any significant internal disease
  • Subjects with a medical history of current or past psoriasis of the skin and/or nails
  • Concurrent lichen planus
  • Subjects who are known to be allergic to any of the test product(s) or any components in the test product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure
  • Nail or anatomic abnormalities of the toe, e.g., genetic nail disorders, primentary disorders, onychogryphosis, trauma to the nail(s) to be treated
  • AIDS or AIDS related complex
  • History of street drug or alcohol abuse
  • Any subject not able to meet the study attendance requirements
  • Subjects who have participated in any other trial of an investigational drug or device within 60 days prior to enrollment or participation in a research study concurrent with this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680134

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-0517
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
J&S Studies
Bryan, Texas, United States, 77802
Endeavor Clinical Trials, PA & San Antonio Podiatry Associates, PC
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Anacor Pharmaceuticals, Inc.
Investigators
Study Director: Karl Beutner, MD, PhD Anacor Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Karl Beutner, M.D., Ph.D., Chief Medical Officer, Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00680134     History of Changes
Other Study ID Numbers: AN2690-ONYC-203
Study First Received: May 15, 2008
Last Updated: May 15, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Anacor Pharmaceuticals, Inc.:
Onychomycosis
Fungal Nail

Additional relevant MeSH terms:
Onychomycosis
Dermatomycoses
Infection
Mycoses
Nail Diseases
Skin Diseases
Skin Diseases, Infectious
Tinea
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014